Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 075057
Company: AUROBINDO PHARMA USA
Company: AUROBINDO PHARMA USA
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | AB | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
08/12/1998 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/1998/75057ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/27/2000 | SUPPL-1 | Manufacturing (CMC)-Packaging |
Label is not available on this site. |
CLOBETASOL PROPIONATE
OINTMENT;TOPICAL; 0.05%
TE Code = AB
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211800 | ALEMBIC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 075057 | AUROBINDO PHARMA USA |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074089 | COSETTE |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 211295 | ENCUBE |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074407 | FOUGERA PHARMS |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208933 | GLENMARK SPECLT |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 215990 | MACLEODS PHARMS LTD |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 208841 | NOVEL LABS INC |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 074248 | TARO |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 209701 | XIROMED |
CLOBETASOL PROPIONATE | CLOBETASOL PROPIONATE | 0.05% | OINTMENT;TOPICAL | Prescription | No | AB | 210199 | ZYDUS PHARMS |